Share Article

This webinar is designed to provide medical device professionals with the information they need to prepare for and manage routine surveillance and unannounced notified body audits. Attendees will learn the rationale, strategies and flow on how to plan for the audit, the audit process and approach, and which company roles should be assigned for notified body audits.

This webinar is designed to provide medical device professionals with the information they need to prepare for and manage routine surveillance and unannounced notified body audits.

Attendees will learn the rationale, strategies and flow on how to plan for the audit, the audit process and approach, and which company roles should be assigned for notified body audits.

This webinar will also show attendees the major changes in medical device CE certification as it relates to unannounced audits and other matters, as a result of EU Commission Recommendation 2013/473/EU. The impact this recommendation has on manufacturers, notified bodies, subcontractors, and suppliers will be explored. In addition, this webinar provides background information on notified bodies’ purpose and CE marking.

Specifically attendees will learn:

The purpose of notified body audits

What steps to take to become EU compliant

The relationship between certifications, product registrations, and ISO 13485 standard

The difference between a notified body, certification body, conformity assessment body and a registrar

The frequency of notified body audits and where to find the most current list of EU notified bodies

Changes and adverse events and who should be notified when they occur

The major changes in medical device CE Certification related to unannounced audits and other matters

How to prepare for a notified body audit

Audit process: What to expect from a notified body’s arrival up to their exit

The timeline to respond to notified body’s audit reports and the sequence to follow in the response

Meet the Presenter:
Vanessa Lopez is a Senior Principal Quality, Regulatory, and Compliance Consultant. Ms. Lopez has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. She possesses over 25 years of experience focused on development, implementation, driving improvements and monitoring of quality assurance, quality control, regulatory compliance, regulatory affairs, quality systems and supplier quality activities. Ms. Lopez has in-depth knowledge and coaches on interpretation and application of US regulations, EU directives, specific country regulations (Japan, Canada, and others), national/international standards and guidance documents.

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.